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2 Day Seminar: A Risk Based Approach to Data Integrity (Arlington, VA, United States - April 19-20, 2018) -
[February 01, 2018]

2 Day Seminar: A Risk Based Approach to Data Integrity (Arlington, VA, United States - April 19-20, 2018) -

The "A Risk Based Approach to Data Integrity" conference has been added to's offering.

This seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity.

Key implementation considerations for a corporate data integrity program, include development of a high-level strategy, identifying and gaining executive sponsorship, focusing on management accountability, implementing tools for knowledge sharing and developing and providing the appropriate levels of training. An effective data integrity program incldes addressing of behavioral factors and drives a strategy that focuses on prevention, detection, response and continuous improvement.

Learning objectives for the seminar include:

  • Data Integrity Requirements
  • Critical Areas of Regulatory Focus and Concern
  • Key Concepts
  • A Framework for Data Governance and Human Factors
  • A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction
  • How to Apply Risk Management to Data Integrity


Day 1 Schedule

  • Lecture 1: Introduction and Background
  • Lecture 2: Data Governance Framework
  • Lecture 3: Quality Risk Management
  • Lecture 4: Data Life Cycle

Day 2 Schedule

  • Lecture 5: Data Integrity Management
  • Lecture 6: Auditing & Audit Trails
  • Lecture 7: Data Integrity for Electronic Records / Electronic Signatures (ERES)
  • Lecture 8: Data Conversions

For more information about this conference visit

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